Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)

NCT00074906 | Completed Phase 3 DMC

• 1 other identifier: BY2001/M1-007
• Study Type: interventional
• Target: 1,200
• Locations: 15 countries
• Sites: 71

Brief Summary

Study to demonstrate that administration of Venticute increases survival of patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygenation impairment.

Conditions

Pneumonia

Keywords

Aspiration of gastric contents

Outcome Measures

Primary Outcomes (1)

• Survival on day 28

  28 days

Secondary Outcomes (1)

• How long the lung and the patient (overall) are recovering

  28 days

Interventions

Venticute DRUG

Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or pneumonia

You may not qualify if:

• Principal source of infection or sepsis is outside the lung
• Severe pre-existing lung disease
• Cancer metastatic to the lung or any end stage malignancy
• History of lung, liver, pancreas, small bowel, or bone marrow/stem cell transplantation
• Patient is morbidly obese
• Patient has a diagnosis of acute necrotizing pancreatitis
• Additional criteria may apply and examination by an investigator is required to determine eligibility.

Sponsors & Collaborators

• Takeda: lead

Study Sites (92)

Altana Pharma/Nycomed

Adelaide SA, 5000, Australia

Location

Altana Pharma/Nycomed

Bedford Park, Adelaide S, 5042, Australia

Location

Altana Pharma/Nycomed

Clayton, VIC, 3158, Australia

Location

Altana Pharma/Nycomed

Fremantle, WA, 6959, Australia

Location

Altana Pharma/Nycomed

Heidelberg, Victoria, 3084, Australia

Location

Altana Pharma/Nycomed

Kingswood, Sydney, NS, 2750, Australia

Location

Altana Pharma/Nycomed

Melbourne VIC, 3004, Australia

Location

Altana Pharma/Nycomed

Perth, Western Australi, 6000, Australia

Location

Altana Pharma/Nycomed

Southport Gold Coast QL, 4215, Australia

Location

Altana Pharma/Nycomed

Victoria, 3050, Australia

Location

Altana Pharma/Nycomed

Victoria, 3128, Australia

Location

Altana Pharma/Nycomed

Woolloongabba, Queens, 4102, Australia

Location

Altana Pharma/Nycomed

Linz, 4021, Austria

Location

Altana Pharma/Nycomed

Vienna, 1090, Austria

Location

Altana Pharma/Nycomed

Brussels, 1090, Belgium

Location

Altana Pharma/Nycomed

Brussels, 1200, Belgium

Location

Altana Pharma/Nycomed

Edegern, 2650, Belgium

Location

Altana Pharma/Nycomed

Ghent, 9000, Belgium

Location

Altana Pharma/Nycomed

Copenhagen NV, 2400, Denmark

Location

Altana Pharma/Nycomed

Hvidovre, 2650, Denmark

Location

Altana Pharma/Nycomed

Kolding, 6000, Denmark

Location

Altana Pharma/Nycomed

Tallinn, 13419, Estonia

Location

Altana Pharma/Nycomed

Tartu, 51014, Estonia

Location

Altana Pharma/Nycomed

Jyväskylä, 40620, Finland

Location

Altana Pharma/Nycomed

Kuopio, 70210, Finland

Location

Altana Pharma/Nycomed

Lappeenranta, 53130, Finland

Location

Altana Pharma/Nycomed

Oulu, 90220, Finland

Location

Altana Pharma/Nycomed

Tampere, 33521, Finland

Location

Altana Pharma/Nycomed

Turku, 20520, Finland

Location

Altana Pharma/Nycomed

Berlin, 10117, Germany

Location

Altana Pharma/Nycomed

Bonn, 53105, Germany

Location

Altana Pharma/Nycomed

Dresden, 1307, Germany

Location

Altana Pharma/Nycomed

Giessen, 35392, Germany

Location

Altana Pharma/Nycomed

Greifswald, 17489, Germany

Location

Altana Pharma/Nycomed

Hanover, 30625, Germany

Location

Altana Pharma/Nycomed

Hofheim, 65702, Germany

Location

Altana Pharma/Nycomed

Konstanz, 78464, Germany

Location

Altana Pharma/Nycomed

Lübeck, 23538, Germany

Location

Altana Pharma/Nycomed

München, 81377, Germany

Location

Altana Pharma/Nycomed

Regensburg, 93042, Germany

Location

Altana Pharma/Nycomed

Tübingen, 72076, Germany

Location

Altana Pharma/Nycomed

Athens, 11527, Greece

Location

Altana Pharma/Nycomed

Dragana, Alexandroupoli, 68100, Greece

Location

Altana Pharma/Nycomed

Thessaloniki, 54636, Greece

Location

Altana Pharma/Nycomed

Voutes, Crete, 71110, Greece

Location

Altana Pharma/Nycomed

Budapest, 1034, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1085, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1106, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1125, Hungary

Location

Altana Pharma/Nycomed

Kistarcsa, 2143, Hungary

Location

Altana Pharma/Nycomed

Szeged, 6720, Hungary

Location

Altana Pharma/Nycomed

Székesfehérvár, 8000, Hungary

Location

Altana Pharma/Nycomed

Vác, 2600, Hungary

Location

Altana Pharma/Nycomed

Afula, 18101, Israel

Location

Altana Pharma/Nycomed

Tel Litwinsky, 52621, Israel

Location

Altana Pharma/Nycomed

Ẕerifin, 70300, Israel

Location

Altana Pharma/Nycomed

Breda, 4818 CK, Netherlands

Location

Altana Pharma/Nycomed

Heerlen, 6401 CX, Netherlands

Location

Altana Pharma/Nycomed

Rotterdam, 3000 CA, Netherlands

Location

Altana Pharma/Nycomed

Tilburg, 5022 GC, Netherlands

Location

Altana Pharma/Nycomed

Christchurch, 8001, New Zealand

Location

Altana Pharma/Nycomed

Hastings, 4201, New Zealand

Location

Altana Pharma/Nycomed

Wellington, 6002, New Zealand

Location

Altana Pharma/Nycomed

Moscow, 105203, Russia

Location

Altana Pharma/Nycomed

Moscow, 111539, Russia

Location

Altana Pharma/Nycomed

Moscow, 115093, Russia

Location

Altana Pharma/Nycomed

Moscow, 115446, Russia

Location

Altana Pharma/Nycomed

Moscow, 123448, Russia

Location

Altana Pharma/Nycomed

Johannesburg, 2006, South Africa

Location

Altana Pharma/Nycomed

Queenswood, 121, South Africa

Location

Altana Pharma/Nycomed

Badajoz, 6080, Spain

Location

Altana Pharma/Nycomed

Barcelona, 6080, Spain

Location

Altana Pharma/Nycomed

Barcelona, 8035, Spain

Location

Altana Pharma/Nycomed

Getafe (Madrid), 28905, Spain

Location

Altana Pharma/Nycomed

Granada, 18013, Spain

Location

Altana Pharma/Nycomed

Madrid, 28046, Spain

Location

Altana Pharma/Nycomed

Palma de Mallorca, 7012, Spain

Location

Altana Pharma/Nycomed

Seville, 41013, Spain

Location

Altana Pharma/Nycomed

Seville, 41014, Spain

Location

Altana Pharma/Nycomed

Bern, 3010, Switzerland

Location

Altana Pharma/Nycomed

Lugano, 6900, Switzerland

Location

Altana Pharma/Nycomed

Winterthur, 8400, Switzerland

Location

Altana Pharma/Nycomed

Zurich, 8091, Switzerland

Location

Altana Pharma/Nycomed

Budapest, 1204, United Kingdom

Location

Altana Pharma/Nycomed

Cardiff, CF14 4XW, United Kingdom

Location

Altana Pharma/Nycomed

Cottingham, HU16 5JQ, United Kingdom

Location

Altana Pharma/Nycomed

Kings Lynn, Norfolk, PE30 4ET, United Kingdom

Location

Altana Pharma/Nycomed

Leeds, LS1 3EX, United Kingdom

Location

Altana Pharma/Nycomed

Leeds, LS9 7JT, United Kingdom

Location

Altana Pharma/Nycomed

Nottingham, NG7 2UH, United Kingdom

Location

Altana Pharma/Nycomed

Reading, RG1 5AN, United Kingdom

Location

Altana Pharma/Nycomed

West Lothian, EHS4 6PP, United Kingdom

Location

Related Publications (1)

• Spragg RG, Taut FJ, Lewis JF, Schenk P, Ruppert C, Dean N, Krell K, Karabinis A, Gunther A. Recombinant surfactant protein C-based surfactant for patients with severe direct lung injury. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1055-61. doi: 10.1164/rccm.201009-1424OC. Epub 2010 Dec 10.

  PMID: 21148720 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Venticute

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roger G. Spragg, MD

  University of California and La Jolla Veterans Affairs Medical Center, San Diego, CA, USA

  PRINCIPAL INVESTIGATOR

• Werner Seeger, MD

  Justus-Liebig-Universität, Gießen, Germany

  PRINCIPAL INVESTIGATOR

• Andreas Günther, MD

  University of Giessen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2003
• First Posted: December 25, 2003
• Study Start: November 1, 2003
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 7, 2012

Record last verified: 2012-01

Locations

AU (2); HU (8); CH (4); BE (4); GR (4); RU (5); DK (3); FI (6); ES (2); DE (12); IL (3); ZA (2); NL (4); GB (9); NZ (3)